Actigraphic Sleep Patterns in Newborns Delivered Via Vacu... | NCT00311142

Studies
Actigraphic Sleep Patterns in Newborns Delivered Via Vacuum Extraction vs. Partum Spontaneous and Cesarean Section

NCT00311142

Sponsor

Sheba Medical Center

Status

Completed

Last Update Posted

Apr 16, 2008Estimated

Enrollment

24Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Apr 2007Actual

Completion Date

Apr 2007Actual

First Submitted Date

Apr 4, 2006

First Submission Date that Met QC Criteria

Apr 4, 2006

First Posted Date

Apr 5, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2008

Last Update Posted Date

Apr 16, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The development of regular sleep-wake cycle is an important factor of the newborn maturation and it has influence on behavior .Factor that may influence the process of the maturation of the sleep-wake cycle is the delivery mode.nd growing. These various states could be detected and measured with actigraphy, using a wrist-watch like device that continuously measures and records the subject's movements.The present study aims to compare vacuum delivery with regular, elective and not elective caesarean sections. We hypothesize that the sleep of vacuum-delivered newborns will be more fragmented then newborns in other delivery modes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy newborn, born either by regular delivery, vacuum extraction or cesarean section

Exclusion Criteria:

Preterms, newborns that need special medical treatment and/or repeated blood sampling as glucose.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

2 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayala Maayan-Metzger, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15129826	Background	Korte J, Hoehn T, Siegmund R. Actigraphic recordings of activity-rest rhythms of neonates born by different delivery modes. Chronobiol Int. 2004 Jan;21(1):95-106. doi: 10.1081/cbi-120027980.